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Dr. Barber: The next steps, and what the study that Susie alluded to earlier, would be to compare these operations to, for instance, an operation that suspends the vagina but using a mesh procedure placed transvaginally. Or to compare this procedure to another operation that’s done through the abdomen, where the vagina is suspended by a mesh bridge from the top of the vagina to the tailbone or the sacrum, called a sacral colpopexy.

So, there are lots of different operations. There are probably three main approaches to treating prolapse of the top of the vagina or prolapse of the uterus. They include the two operations that we did, the native tissue transvaginal operations; a transvaginal mesh suspension; and then an abdominal mesh suspension called a sacral colpopexy.

So the next steps would really be to compare these operations to those other two in the right patient population and comparing both efficacy and safety.

Dr. Meikle: … That’s why OPTIMAL, this study, was so helpful, and an important piece of the basic construction of how we move forward in studying treatments is that now we can use these results to help us inform the design of the next studies, which we have done. We have chosen one procedure, instead of using both, because it simplified the next study.

And it simplifies it because we can describe it better when we’re trying to explain it to somebody who might be interested in participating. It also reduced our cost because you don’t have to include as many participants. So, we are using these results now. We waited for the results of this trial before moving on to the next one. It’s really important.

Well, the next study that we’re currently carrying out, the SUPeR trial [Study of Uterine Prolapse Procedures Randomized Trial], is comparing the uterosacral ligament fixation suspension to, as Matt was describing, a procedure where we actually don’t remove the uterus, but kind of tack that uterus up at the top of the pelvis with a mesh device.

So, it’s a small amount of mesh. And this study would give women the option of keeping their uterus, which is something many of these women with pelvic organ prolapse haven’t had the option for, there’s been very little information about.

One of the main questions has always been if we cut those ligaments that attach the uterus to the back of the pelvic floor, are we really increasing the risk of a future failure down the road? So, that’s—this study allows us to do that comparison simply by, we’re just choosing one of these procedures.